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Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer (PGx-SELECT)

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cisplatin
Cetuximab
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and neck cancer, pharmacogenetics, chemoradiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy proven squamous cell carcinoma of the head and neck, including of the oral cavity, oropharynx, hypopharynx, or larynx
  • Locally advanced, Stage III or IVB disease and a candidate for primary therapy using chemotherapy and radiation with curative intent
  • Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is primary modality of treatment
  • No previous chemotherapy, radiation, or surgery for the diagnosis of head and neck cancer
  • ECOG performance status 0 or 1
  • Negative pregnancy test
  • Hemoglobin >/= 8.0
  • Absolute neutrophil count >/= 1500
  • Platelet count >/= 100,000
  • GFR > 50 mL/min
  • Total bilirubin </= 1.5 upper limits of normal
  • AST and ALT </= 2.5 times upper limits of normal
  • No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast.
  • Ability and willingness to give consent
  • Subjects must in the opinion of the Investigator be capable of complying with the protocol

Exclusion Criteria:

  • Primary tumors of the nasopharynx, sinuses, and salivary glands
  • Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
  • Major surgery within 3 weeks prior to study entry
  • Known hypersensitivity to cisplatin or cetuximab
  • Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study including: unstable angina, serious uncontrolled cardiac arrhythmia, active or uncontrolled infectious disorder, myocardial infarction </= 6 months prior to study entry
  • Psychiatric illness that would limit compliance with study requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Cetuximab

    Cisplatin

    Arm Description

    patients with 2 or fewer genetic variants will receive cetuximab

    Subjects with 3 to 8 genetic variants will receive cisplatin

    Outcomes

    Primary Outcome Measures

    Progression-free survival

    Secondary Outcome Measures

    Objective response
    Overall survival
    Toxicity
    Quality of Life

    Full Information

    First Posted
    April 13, 2009
    Last Updated
    March 26, 2015
    Sponsor
    Georgetown University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00881114
    Brief Title
    Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer
    Acronym
    PGx-SELECT
    Official Title
    A Prospective Phase II Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator decided it was not feasible to conduct this study
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Georgetown University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a study for patients with head and neck cancer who will be receiving chemotherapy and radiation therapy for their disease. The purpose of this study is to see if the investigators can use genetic differences between patients to select the right drug to use with radiation therapy. This type of genetic testing is called pharmacogenetics. Currently there are two drugs used to treat head and neck cancer that have provided a benefit when given with radiation compared to radiation alone in previous studies. These two drugs are cisplatin and cetuximab (Erbitux). In this trial, the investigators will test whether genetic differences between patients can be used to pick which drug they should receive. A recent study that looked back to see how well patients with head and neck cancer responded to treatment with cisplatin showed that genetic differences in a few genes were associated with who did and who did not survive their cancer. The investigators are taking that finding and using it to test patients for these genetic differences to determine whether they should receive cisplatin or cetuximab. In other words, the investigators are trying to take what is essentially a flip of the coin choice between these two drugs, and instead use individual patient's genetic differences to make-and hopefully improve- this choice.
    Detailed Description
    Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for variations at four SNP loci in 3 genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin, while patients with 2 or fewer variants will receive cetuximab.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    Head and neck cancer, pharmacogenetics, chemoradiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cetuximab
    Arm Type
    Experimental
    Arm Description
    patients with 2 or fewer genetic variants will receive cetuximab
    Arm Title
    Cisplatin
    Arm Type
    Experimental
    Arm Description
    Subjects with 3 to 8 genetic variants will receive cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    cis-diamminedichloridoplatinum(II), CDDP
    Intervention Description
    Intensity modulated radiation therapy with concurrent chemotherapy. Cisplatin will be administered at a dose of 100 mg/m2 during weeks 1, 4, and 7 of radiation therapy. Post treatment neck dissection will be performed if clinically indicated.
    Intervention Type
    Drug
    Intervention Name(s)
    Cetuximab
    Other Intervention Name(s)
    Erbitux
    Intervention Description
    Intensity modulated Radiation Therapy with concurrent chemotherapy. Cetuximab will be administered beginning at a dose of 400 mg/m2 the week before radiation commences, then at a dose of 250 mg/m2 weekly during weeks 1 to 7. Post treatment neck dissection will be performed if clinically indicated.
    Primary Outcome Measure Information:
    Title
    Progression-free survival
    Time Frame
    36months
    Secondary Outcome Measure Information:
    Title
    Objective response
    Time Frame
    36 months
    Title
    Overall survival
    Time Frame
    36 months
    Title
    Toxicity
    Time Frame
    8 weeks
    Title
    Quality of Life
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Biopsy proven squamous cell carcinoma of the head and neck, including of the oral cavity, oropharynx, hypopharynx, or larynx Locally advanced, Stage III or IVB disease and a candidate for primary therapy using chemotherapy and radiation with curative intent Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is primary modality of treatment No previous chemotherapy, radiation, or surgery for the diagnosis of head and neck cancer ECOG performance status 0 or 1 Negative pregnancy test Hemoglobin >/= 8.0 Absolute neutrophil count >/= 1500 Platelet count >/= 100,000 GFR > 50 mL/min Total bilirubin </= 1.5 upper limits of normal AST and ALT </= 2.5 times upper limits of normal No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast. Ability and willingness to give consent Subjects must in the opinion of the Investigator be capable of complying with the protocol Exclusion Criteria: Primary tumors of the nasopharynx, sinuses, and salivary glands Acute treatment for an infection or other serious medical illness within 14 days prior to study entry Major surgery within 3 weeks prior to study entry Known hypersensitivity to cisplatin or cetuximab Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study including: unstable angina, serious uncontrolled cardiac arrhythmia, active or uncontrolled infectious disorder, myocardial infarction </= 6 months prior to study entry Psychiatric illness that would limit compliance with study requirements
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Deeken, MD
    Organizational Affiliation
    Georgetown University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Study Using Pharmacogenetics to Select Treatment for Head and Neck Cancer

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